Search Results

The SkinClear Q-Switched Nd: YAG Laser is indicated at the 1064 nm wavelength for dark ink tattoo removal, the removal of pigmented lesions. and the removal or lightening of hair. Indicated for use on all skin types (Fitzpatrick I-IV)

The SkinClear Q-Switched Nd: YAG Laser is indicated at the 532 nm wavelength for red ink tattoo removal, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, ephildes). Indicated for use on all skin types (Fitzpatrick I-IV)

The SkinClear Q-Switched Nd: YAG Laser is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD), a handpiece which contains the light source which is connected to the console by a power cord, and an on/off footswitch.

The provided text does not describe acceptance criteria for a study or data proving a device meets such criteria. Instead, it is a 510(k) summary for the SkinClear Q-Switched Nd:YAG Laser, submitted to the FDA. This document states that no nonclinical or clinical performance data was provided to support the submission.

The FDA's determination of substantial equivalence for this device was based on a comparison of its technological characteristics to a legally marketed predicate device (Sandstone Medical Technologies, LLC UltraLight II Nd:YAG Laser System (K041011)). The key aspect of this comparison was that both devices share the same wavelengths, energy output, pulse duration, and pulse repetition rate.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are reported.
2. Sample size used for the test set and the data provenance: No test set was used as no clinical or nonclinical studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set data was provided.
4. Adjudication method for the test set: Not applicable, as no test set data was provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study was done, as no clinical data was submitted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a laser device, not an algorithm.
7. The type of ground truth used: No ground truth was established, as no performance studies were conducted.
8. The sample size for the training set: Not applicable, as no training set was used.
9. How the ground truth for the training set was established: Not applicable, as no training set was used.

Ask a specific question about this device

Indicated at 2940 nm for Fitzpatrick skin types I-V for coagulation, vaporization, ablation or cutting of soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology. Specifically indicated for skin resurfacing, treatment of wrinkles, and superficial skin lesions.

The LaserPeel Soft-MET Modified Erbium Laser is a compact self-contained device that delivers a beam of laser energy at an infrared wavelength of 2940 nm to the treatment site. The LaserPeel Soft-MET Modified Erbium Laser consists of four primary components:

1. A console which houses the power supply, electronics, cooling system, and liquid crystal display screen (LCD);
2. A handpiece which contains the laser cavity and optical delivery system and is connected to the console by an umbilical cord:
3. An on/off footswitch; and
4. An integrated trolley/cart.
   The LaserPeel Soft-MET Modified Erbium Laser is not battery operated, but is controlled and operated with the aid of computer software.

The provided 510(k) summary for the LaserPeel Soft-MET Modified Erbium Laser does not include any acceptance criteria or a study demonstrating the device meets such criteria.

In fact, the document explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

Therefore, I cannot populate the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The 510(k) process in this instance seemingly granted substantial equivalence based on the device's technical characteristics and intended use being similar to legally marketed predicate devices, rather than requiring new performance studies with specific acceptance criteria.

Ask a specific question about this device

The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.

530 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, and epheleides (freckles) * Benign cutaneous lesions including warts, scars, and striae

560 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae

585 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae

640 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-IV for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction

690 - 1400 nm wavelength is indicated for Fitzpatrick skin types IV and V for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction

The NannoLight Intense Pulsed Light System is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD) which displays the settings of power, pulse width, and pulse count which are manually adjusted by a touch screen display panel, a handpiece which contains the light source connected to the console by a power cord, and an on/off footswitch. The NannoLight Intense Pulsed Light System is not battery operated, but is controlled and operated with the aid of computer software.

The NannoLight Intense Pulsed Light System (K082033) 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

Instead of presenting performance data, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices (Sciton Profile BBL System (K032460) and Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems (K020839)) for its clearance. This means that the device's safety and effectiveness are supported by its similarity in design, intended use, and operational principles to already approved devices, rather than a novel study demonstrating its specific performance against defined metrics.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment, as this information is not present in the provided text.

Ask a specific question about this device

1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae. Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.

1320 nm: For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser is a compact self-contained device that delivers a beam of laser energy at infrared wavelengths of 1064 nm and 1320 nm to the treatment site. The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser consists of six (6) primary components:

1. Laser console;
2. Internal computer;
3. Control panel and display;
4. Optical delivery system;
5. Hand set with integrated cooling (chilled sapphire optical window);
6. Foot switch
   The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser is not battery operated, but is controlled and operated with the aid of computer software.

The provided text does not describe specific acceptance criteria and a study proving the device meets those criteria. Instead, it is a 510(k) summary for the SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving performance against predefined acceptance criteria through a clinical study.

Here's a breakdown of why this information is absent and what the document does provide:

• No Clinical Performance Data: The document explicitly states "Clinical Performance Data: None" and "Nonclinical Performance Data: None." This immediately tells us that no studies were conducted to gather performance metrics against acceptance criteria for this specific device.
• Substantial Equivalence: The conclusion states: "The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser shares the same indications for use, similar design features (including wavelengths, laser medium, power supply, cooling and control systems), functional features (including power output, repetition rate, energy, spot sizes and energy fluence), and is therefore substantially equivalent to the above legally marketed laser systems currently in commercial distribution." This is the core of a 510(k) submission – demonstrating similarity to a device already on the market, avoiding the need for new clinical trials in many cases.

Therefore, for the specific questions asked, the answers are largely "Not applicable" or "None provided" based on the nature of this 510(k) submission.

Here's how to answer based on the provided document, addressing each point:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not applicable, as no clinical or performance test set data specific to this device is provided.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Comparative Effectiveness Study: No, not applicable. This is a laser device, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance Study: No, not applicable. This is a physical laser device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable, as no clinical study or performance data generation for this specific device is described.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable, as no algorithm training or clinical study for this device is described.

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not applicable.

Summary based on the document:

This 510(k) submission for the SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser relies entirely on demonstrating substantial equivalence to existing, legally marketed predicate devices. No new clinical performance data, nonclinical performance data, or studies (such as those involving test sets, training sets, experts, or multi-reader studies) were submitted for this specific device. The device's approval is based on its similar design, functional features, and indications for use as compared to the listed predicate devices.

Ask a specific question about this device